The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.

This news organization will update this article as more information becomes available.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.

This news organization will update this article as more information becomes available.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.

This news organization will update this article as more information becomes available.

A version of this article first appeared on Medscape.com.

Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.

Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.

In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.

The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.

Overall, among the patients in the TIS group, there was a significantly greater reduction in P. aeruginosa density, compared with placebo patients, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.

In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.

Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.

The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.

However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.

The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.

Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.

In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.

The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.

Overall, among the patients in the TIS group, there was a significantly greater reduction in P. aeruginosa density, compared with placebo patients, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.

In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.

Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.

The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.

However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.

The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.

Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.

In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.

The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.

Overall, among the patients in the TIS group, there was a significantly greater reduction in P. aeruginosa density, compared with placebo patients, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.

In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.

Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.

The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.

However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.

The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of lice and scabies decreased significantly among children and adults in North Carolina during the confinement period of the COVID-19 pandemic, between March 2020 and February 2021, according to a report in Pediatric Dermatology.

When COVID-19 was declared a public health emergency by the World Health Organization in March 2020, many countries including the United States enacted lockdown and isolation measures to help contain the spread of the disease. Since scabies and lice are both spread by direct contact, “we hypothesized that the nationwide lockdown would influence the transmission of these two conditions among individuals,” wrote Marianne Bonanno, MD, of the University of North Carolina, Chapel Hill, and colleagues.

“The pandemic created a unique opportunity for real-life observations following physical distancing measures being put in place,” coauthor Christopher Sayed, MD, associate professor of dermatology at UNC, said in an interview. “It makes intuitive sense that since lice and scabies spread by cost physical contact that rates would decrease with school closures and other physical distancing measures. Reports from other countries in which extended families more often live together and were forced to spend more time in close quarters saw increased rates so it was interesting to see this contrast,” he noted.

In the study, the researchers reviewed data from 1,858 cases of adult scabies, 893 cases of pediatric scabies, and 804 cases of pediatric lice reported in North Carolina between March 2017 and February 2021. They compared monthly cases of scabies and lice, and prescriptions during the period before the pandemic (March 2017 to February 2020), and during the pandemic (March 2020 to February 2021).

Pediatric lice cases decreased by 60.6% over the study period (P < .001). Significant decreases also occurred in adult scabies (31.1%, P < .001) and pediatric scabies (39%, P < .01).

The number of prescriptions for lice and scabies also decreased significantly (P < .01) during the study period, although these numbers differed from the actual cases. Prescriptions decreased by 41.4%, 29.9%, and 69.3% for pediatric scabies, adult scabies, and pediatric lice, respectively.

Both pediatric scabies and pediatric lice showed a greater drop in prescriptions than in cases, while the drop in prescriptions for adult scabies was slightly less than the drop in cases.

The difference in the decreased numbers between cases and prescriptions may stem from the decrease in close contacts during the pandemic, which decreased the need for multiple prescriptions, but other potential explanations could be examined in future studies, the researchers wrote in their discussion.

The study findings were limited by several factors including the cross-sectional design and potential underdiagnosis and underreporting, as well as the focus only on a population in a single state, which may limit generalizability, the researchers noted.

However, the results offer preliminary insights on the impact of COVID-19 restrictions on scabies and lice, and suggest the potential value of physical distancing to reduce transmission of both conditions, especially in settings such as schools and prisons, to help contain future outbreaks, they concluded.

The study findings reinforce physical contact as the likely route of disease transmission, for lice and scabies, Dr. Sayed said in the interview. “It’s possible distancing measures on a small scale could be considered for outbreaks in institutional settings, though the risks of these infestations are much lower than with COVID-19,” he said. “It will be interesting to observe trends as physical distancing measures end to see if cases rebound in the next few years,” he added.

Drop in cases likely temporary

“Examining the epidemiology of different infectious diseases over time is an interesting and important area of study,” said Sheilagh Maguiness, MD, associate professor of dermatology and pediatrics at the University of Minnesota, Minneapolis, who was asked to comment on the results.

“The pandemic dramatically altered the daily lives of adults and children across the globe, and we can learn a lot from studying how social distancing and prolonged masking has made an impact on the incidence and prevalence of different infectious illnesses in the country and across the world,” she said in an interview.

Dr. Maguiness said she was not surprised by the study findings. “In fact, other countries have published similar studies documenting a reduction in both head lice and scabies infestations during the time of the pandemic,” she said. “In France, it was noted that during March to December 2020, there was a reduction in sales for topical head lice and scabies treatments of 44% and 14%, respectively. Similarly, a study from Argentina documented a decline in head lice infestations by about 25% among children,” she said.

“I personally noted a marked decrease in both of these diagnoses among children in my own clinic,” she added.

“Since both of these conditions are spread through close physical contact with others, it makes sense that there would be a steep decline in ectoparasitic infections during times of social distancing. However, anecdotally we are now diagnosing and treating these infestations again more regularly in our clinic,” said Dr. Maguiness. “As social distancing relaxes, I would expect that the incidence of both head lice and scabies will again increase.” 

The study received no outside funding. The researchers and Dr. Maguiness had no financial conflicts to disclose.

The incidence of lice and scabies decreased significantly among children and adults in North Carolina during the confinement period of the COVID-19 pandemic, between March 2020 and February 2021, according to a report in Pediatric Dermatology.

When COVID-19 was declared a public health emergency by the World Health Organization in March 2020, many countries including the United States enacted lockdown and isolation measures to help contain the spread of the disease. Since scabies and lice are both spread by direct contact, “we hypothesized that the nationwide lockdown would influence the transmission of these two conditions among individuals,” wrote Marianne Bonanno, MD, of the University of North Carolina, Chapel Hill, and colleagues.

“The pandemic created a unique opportunity for real-life observations following physical distancing measures being put in place,” coauthor Christopher Sayed, MD, associate professor of dermatology at UNC, said in an interview. “It makes intuitive sense that since lice and scabies spread by cost physical contact that rates would decrease with school closures and other physical distancing measures. Reports from other countries in which extended families more often live together and were forced to spend more time in close quarters saw increased rates so it was interesting to see this contrast,” he noted.

In the study, the researchers reviewed data from 1,858 cases of adult scabies, 893 cases of pediatric scabies, and 804 cases of pediatric lice reported in North Carolina between March 2017 and February 2021. They compared monthly cases of scabies and lice, and prescriptions during the period before the pandemic (March 2017 to February 2020), and during the pandemic (March 2020 to February 2021).

Pediatric lice cases decreased by 60.6% over the study period (P < .001). Significant decreases also occurred in adult scabies (31.1%, P < .001) and pediatric scabies (39%, P < .01).

The number of prescriptions for lice and scabies also decreased significantly (P < .01) during the study period, although these numbers differed from the actual cases. Prescriptions decreased by 41.4%, 29.9%, and 69.3% for pediatric scabies, adult scabies, and pediatric lice, respectively.

Both pediatric scabies and pediatric lice showed a greater drop in prescriptions than in cases, while the drop in prescriptions for adult scabies was slightly less than the drop in cases.

The difference in the decreased numbers between cases and prescriptions may stem from the decrease in close contacts during the pandemic, which decreased the need for multiple prescriptions, but other potential explanations could be examined in future studies, the researchers wrote in their discussion.

The study findings were limited by several factors including the cross-sectional design and potential underdiagnosis and underreporting, as well as the focus only on a population in a single state, which may limit generalizability, the researchers noted.

However, the results offer preliminary insights on the impact of COVID-19 restrictions on scabies and lice, and suggest the potential value of physical distancing to reduce transmission of both conditions, especially in settings such as schools and prisons, to help contain future outbreaks, they concluded.

The study findings reinforce physical contact as the likely route of disease transmission, for lice and scabies, Dr. Sayed said in the interview. “It’s possible distancing measures on a small scale could be considered for outbreaks in institutional settings, though the risks of these infestations are much lower than with COVID-19,” he said. “It will be interesting to observe trends as physical distancing measures end to see if cases rebound in the next few years,” he added.

Drop in cases likely temporary

“Examining the epidemiology of different infectious diseases over time is an interesting and important area of study,” said Sheilagh Maguiness, MD, associate professor of dermatology and pediatrics at the University of Minnesota, Minneapolis, who was asked to comment on the results.

“The pandemic dramatically altered the daily lives of adults and children across the globe, and we can learn a lot from studying how social distancing and prolonged masking has made an impact on the incidence and prevalence of different infectious illnesses in the country and across the world,” she said in an interview.

Dr. Maguiness said she was not surprised by the study findings. “In fact, other countries have published similar studies documenting a reduction in both head lice and scabies infestations during the time of the pandemic,” she said. “In France, it was noted that during March to December 2020, there was a reduction in sales for topical head lice and scabies treatments of 44% and 14%, respectively. Similarly, a study from Argentina documented a decline in head lice infestations by about 25% among children,” she said.

“I personally noted a marked decrease in both of these diagnoses among children in my own clinic,” she added.

“Since both of these conditions are spread through close physical contact with others, it makes sense that there would be a steep decline in ectoparasitic infections during times of social distancing. However, anecdotally we are now diagnosing and treating these infestations again more regularly in our clinic,” said Dr. Maguiness. “As social distancing relaxes, I would expect that the incidence of both head lice and scabies will again increase.” 

The study received no outside funding. The researchers and Dr. Maguiness had no financial conflicts to disclose.

The incidence of lice and scabies decreased significantly among children and adults in North Carolina during the confinement period of the COVID-19 pandemic, between March 2020 and February 2021, according to a report in Pediatric Dermatology.

When COVID-19 was declared a public health emergency by the World Health Organization in March 2020, many countries including the United States enacted lockdown and isolation measures to help contain the spread of the disease. Since scabies and lice are both spread by direct contact, “we hypothesized that the nationwide lockdown would influence the transmission of these two conditions among individuals,” wrote Marianne Bonanno, MD, of the University of North Carolina, Chapel Hill, and colleagues.

“The pandemic created a unique opportunity for real-life observations following physical distancing measures being put in place,” coauthor Christopher Sayed, MD, associate professor of dermatology at UNC, said in an interview. “It makes intuitive sense that since lice and scabies spread by cost physical contact that rates would decrease with school closures and other physical distancing measures. Reports from other countries in which extended families more often live together and were forced to spend more time in close quarters saw increased rates so it was interesting to see this contrast,” he noted.

In the study, the researchers reviewed data from 1,858 cases of adult scabies, 893 cases of pediatric scabies, and 804 cases of pediatric lice reported in North Carolina between March 2017 and February 2021. They compared monthly cases of scabies and lice, and prescriptions during the period before the pandemic (March 2017 to February 2020), and during the pandemic (March 2020 to February 2021).

Pediatric lice cases decreased by 60.6% over the study period (P < .001). Significant decreases also occurred in adult scabies (31.1%, P < .001) and pediatric scabies (39%, P < .01).

The number of prescriptions for lice and scabies also decreased significantly (P < .01) during the study period, although these numbers differed from the actual cases. Prescriptions decreased by 41.4%, 29.9%, and 69.3% for pediatric scabies, adult scabies, and pediatric lice, respectively.

Both pediatric scabies and pediatric lice showed a greater drop in prescriptions than in cases, while the drop in prescriptions for adult scabies was slightly less than the drop in cases.

The difference in the decreased numbers between cases and prescriptions may stem from the decrease in close contacts during the pandemic, which decreased the need for multiple prescriptions, but other potential explanations could be examined in future studies, the researchers wrote in their discussion.

The study findings were limited by several factors including the cross-sectional design and potential underdiagnosis and underreporting, as well as the focus only on a population in a single state, which may limit generalizability, the researchers noted.

However, the results offer preliminary insights on the impact of COVID-19 restrictions on scabies and lice, and suggest the potential value of physical distancing to reduce transmission of both conditions, especially in settings such as schools and prisons, to help contain future outbreaks, they concluded.

The study findings reinforce physical contact as the likely route of disease transmission, for lice and scabies, Dr. Sayed said in the interview. “It’s possible distancing measures on a small scale could be considered for outbreaks in institutional settings, though the risks of these infestations are much lower than with COVID-19,” he said. “It will be interesting to observe trends as physical distancing measures end to see if cases rebound in the next few years,” he added.

Drop in cases likely temporary

“Examining the epidemiology of different infectious diseases over time is an interesting and important area of study,” said Sheilagh Maguiness, MD, associate professor of dermatology and pediatrics at the University of Minnesota, Minneapolis, who was asked to comment on the results.

“The pandemic dramatically altered the daily lives of adults and children across the globe, and we can learn a lot from studying how social distancing and prolonged masking has made an impact on the incidence and prevalence of different infectious illnesses in the country and across the world,” she said in an interview.

Dr. Maguiness said she was not surprised by the study findings. “In fact, other countries have published similar studies documenting a reduction in both head lice and scabies infestations during the time of the pandemic,” she said. “In France, it was noted that during March to December 2020, there was a reduction in sales for topical head lice and scabies treatments of 44% and 14%, respectively. Similarly, a study from Argentina documented a decline in head lice infestations by about 25% among children,” she said.

“I personally noted a marked decrease in both of these diagnoses among children in my own clinic,” she added.

“Since both of these conditions are spread through close physical contact with others, it makes sense that there would be a steep decline in ectoparasitic infections during times of social distancing. However, anecdotally we are now diagnosing and treating these infestations again more regularly in our clinic,” said Dr. Maguiness. “As social distancing relaxes, I would expect that the incidence of both head lice and scabies will again increase.” 

The study received no outside funding. The researchers and Dr. Maguiness had no financial conflicts to disclose.

Longitudinal progression of parenchymal changes on CT images — also referred to as quantitative interstitial abnormalities (QIA) – is independently associated with decreased lung function and an increased all-cause mortality risk, an analysis of two cohorts of ever-smokers indicates. And among the main risk factors for QIA progression is smoking.

“These abnormalities have gone by a few different names but fundamentally, they are high density findings of chest CT that in some cases represent early or subtle evidence of pulmonary fibrosis,” Samuel Ash, MD, MPH, assistant professor of medicine, Brigham and Women’s Hospital, Boston, told this news organization.

“I think this just adds to the huge list of reasons why people should quit smoking. So when I see someone with visual evidence of this type of change on their chest CT, I make sure to emphasize that while they don’t have interstitial lung disease [ILD] yet, these findings suggest they may be susceptible to lung injury from tobacco smoke and that if they don’t stop smoking now, they are at risk for a disease like interstitial pulmonary fibrosis [IPF] which is a highly morbid disease with a high mortality risk,” he added.

The study was published online in the journal CHEST.
 

Ever-smoking cohorts

Analysis of QIA progression on CT chest scans was carried out on participants from the Genetic Epidemiology of COPD (COPDGene) study as well as those from the Pittsburgh Lung Screening Study (PLuSS). COPDGene was a prospective cohort of over 10,300 ever-smokers with at least a 10–pack-year smoking history between the ages of 45 and 80. Participants underwent a series of tests including chest CT scans at baseline between 2006 and 2011 and again approximately 5 years later.

Patients with a postbronchodilator forced expiratory volume in 1 second (FEV₁) of 80% or more of predicted and a FEV₁-to-FVC (forced vital capacity) ratio of at least 0.7 were defined to have GOLD stage 0 disease while those with a postbronchodilator FEV₁ of 80% or less than predicted and a FEV₁-to-FVC ratio of at least 0.7 were defined to have preserved ratio impaired spirometry (PRISm) disease.

PLuSS involved 3,642 ever-smokers between the ages of 50 years and 79 years with at least a 12.5–pack-year history with no prior history of lung cancer. Participants again underwent a series of tests including a CT scan on visit 1 between 2002 and 2005 and then a second CT scan at a second visit almost 9 years later. “In the COPDGene cohort, 4,635 participants had complete clinical data, CT scans and spirometry from visits 1 and 2 for analysis,” the authors reported.

At visit 1 almost 48% of participants were current smokers and the mean pack-year history of the cohort was 41.9 years. The mean time between visits 1 and 2 was 5.6 years. Both the mean prebronchodilator FEV₁ as well as the mean FVC decreased between visits 1 and 2. For example, the mean prebronchodilator FEV₁ dropped from 2.2 liters to 2.0 liters between visits 1 and 2 while the mean prebronchodilator FVC decreased from 3.2 liters to 3.0 liters between the first and second visits.

In the PLuSS cohort, 1,307 participants had complete imaging and spirometry data available for visits 1 and 2 for analysis. The mean time between visits 1 and 2 was 8.6 years. Over 59% of the cohort were current smokers with a mean pack-year history of 65. Again, the mean prebronchodilator FEV1 and FVC both dropped between visit 1 and 2, as the authors note.

The mean prebronchodilator FEV1, for example, decreased from 2.5 liters to 2.1 liters between visits 1 and 2 while the mean prebronchodilator FVC dropped from 3.6 liters to 3.2 liters during the same interval. Looking at risk factors associated with QIA progression, investigators note that each additional year of baseline age was associated with a higher annual increase in QIA by 0.01% per year (95% confidence interval, 0.01%-0.02%; P < .001) in the COPDGene cohort and a 0.02% increase (95% CI, 0.01%-0.02%; P < .001) in the PLuSS cohort.

Female sex in turn was associated with a 0.07% per year (95% CI, 0.02%-0.12%; P = .003) higher increase in the QIA, compared with men in the COPDGene cohort and a 0.14% (95% CI, 0.02%-0.26%; P = .025) per year higher increase in the QIA in the PLuSS cohort. Current smoking status was only associated with a higher rate of QIA progression in the COPDGene cohort at a rate of 0.10% per year (95% CI, 0.06%-0.15%; P < .001).

Lastly, every copy of the minor allele of the MUIC5B promoter polymorphism was associated with a 0.12% per year (95% CI, 0.07%-0.16%; P < .0001) increase in QIA in the COPDGene cohort as well.
 

Smoking cessation

Smoking cessation is the obvious first step for patients with evidence of QIA progression but physicians can probably do more for these patients sooner, Dr. Ash said. “If we use heart disease as an analogy, we don’t want to start treating someone until they have a heart attack or are in heart failure, we start by checking their cholesterol and blood pressure and treating them with medications to prevent progression.”

Similarly, physicians need to start thinking about IPF and other lung diseases in the same way. For IPF, medications such as pirfenidone (Esbriet) and nintedanib (Ofev) do not reverse prior lung damage but they do slow disease progression and physicians need to initiate treatment before patients are short of breath, not after. Meantime, Dr. Ash advised physicians that, if they have a patient who is getting a CT scan for whatever reason, they should keep a close eye on whether or not patients have any of these interstitial changes and, if they do, then if the changes are getting worse.

“These patients are likely to be the ones who are going to develop IPF and who may benefit from ongoing imaging surveillance,” he said. And while clinicians may not yet be ready to use a quantitative tool at the bedside, “this tool – or one like it – is coming and we have to start thinking about how to incorporate these types of devices into our clinical practice.”
 

Temporal changes

Asked to comment on the findings, Surya Bhatt, MD, associate professor of medicine at the University of Alabama at Birmingham, said that the study advances the community’s understanding of the relationship between temporal changes in objectively measured interstitial lung abnormalities and several important clinical outcomes, including lung function decline and mortality. “Several risk factors for progression were also identified,” he noted.

“And these results make a case for initiating clinical trials to determine whether early treatment with existing antifibrotic medications in these high risk individuals can decrease the perpetuation of these permanent lung changes,” Dr. Bhatt said.

The COPDGene study was supported in part by contributions made by an industry advisory board. Dr. Ash was supported in part by Quantitative Imaging Solutions. Dr. Bhatt declared that he has receiving consulting fees or has service on advisory boards for Boehringer Ingelheim and Sanofi/Regeneron. He ha also received fee for CME from IntegrityCE.

Longitudinal progression of parenchymal changes on CT images — also referred to as quantitative interstitial abnormalities (QIA) – is independently associated with decreased lung function and an increased all-cause mortality risk, an analysis of two cohorts of ever-smokers indicates. And among the main risk factors for QIA progression is smoking.

“These abnormalities have gone by a few different names but fundamentally, they are high density findings of chest CT that in some cases represent early or subtle evidence of pulmonary fibrosis,” Samuel Ash, MD, MPH, assistant professor of medicine, Brigham and Women’s Hospital, Boston, told this news organization.

“I think this just adds to the huge list of reasons why people should quit smoking. So when I see someone with visual evidence of this type of change on their chest CT, I make sure to emphasize that while they don’t have interstitial lung disease [ILD] yet, these findings suggest they may be susceptible to lung injury from tobacco smoke and that if they don’t stop smoking now, they are at risk for a disease like interstitial pulmonary fibrosis [IPF] which is a highly morbid disease with a high mortality risk,” he added.

The study was published online in the journal CHEST.
 

Ever-smoking cohorts

Analysis of QIA progression on CT chest scans was carried out on participants from the Genetic Epidemiology of COPD (COPDGene) study as well as those from the Pittsburgh Lung Screening Study (PLuSS). COPDGene was a prospective cohort of over 10,300 ever-smokers with at least a 10–pack-year smoking history between the ages of 45 and 80. Participants underwent a series of tests including chest CT scans at baseline between 2006 and 2011 and again approximately 5 years later.

Patients with a postbronchodilator forced expiratory volume in 1 second (FEV₁) of 80% or more of predicted and a FEV₁-to-FVC (forced vital capacity) ratio of at least 0.7 were defined to have GOLD stage 0 disease while those with a postbronchodilator FEV₁ of 80% or less than predicted and a FEV₁-to-FVC ratio of at least 0.7 were defined to have preserved ratio impaired spirometry (PRISm) disease.

PLuSS involved 3,642 ever-smokers between the ages of 50 years and 79 years with at least a 12.5–pack-year history with no prior history of lung cancer. Participants again underwent a series of tests including a CT scan on visit 1 between 2002 and 2005 and then a second CT scan at a second visit almost 9 years later. “In the COPDGene cohort, 4,635 participants had complete clinical data, CT scans and spirometry from visits 1 and 2 for analysis,” the authors reported.

At visit 1 almost 48% of participants were current smokers and the mean pack-year history of the cohort was 41.9 years. The mean time between visits 1 and 2 was 5.6 years. Both the mean prebronchodilator FEV₁ as well as the mean FVC decreased between visits 1 and 2. For example, the mean prebronchodilator FEV₁ dropped from 2.2 liters to 2.0 liters between visits 1 and 2 while the mean prebronchodilator FVC decreased from 3.2 liters to 3.0 liters between the first and second visits.

In the PLuSS cohort, 1,307 participants had complete imaging and spirometry data available for visits 1 and 2 for analysis. The mean time between visits 1 and 2 was 8.6 years. Over 59% of the cohort were current smokers with a mean pack-year history of 65. Again, the mean prebronchodilator FEV1 and FVC both dropped between visit 1 and 2, as the authors note.

The mean prebronchodilator FEV1, for example, decreased from 2.5 liters to 2.1 liters between visits 1 and 2 while the mean prebronchodilator FVC dropped from 3.6 liters to 3.2 liters during the same interval. Looking at risk factors associated with QIA progression, investigators note that each additional year of baseline age was associated with a higher annual increase in QIA by 0.01% per year (95% confidence interval, 0.01%-0.02%; P < .001) in the COPDGene cohort and a 0.02% increase (95% CI, 0.01%-0.02%; P < .001) in the PLuSS cohort.

Female sex in turn was associated with a 0.07% per year (95% CI, 0.02%-0.12%; P = .003) higher increase in the QIA, compared with men in the COPDGene cohort and a 0.14% (95% CI, 0.02%-0.26%; P = .025) per year higher increase in the QIA in the PLuSS cohort. Current smoking status was only associated with a higher rate of QIA progression in the COPDGene cohort at a rate of 0.10% per year (95% CI, 0.06%-0.15%; P < .001).

Lastly, every copy of the minor allele of the MUIC5B promoter polymorphism was associated with a 0.12% per year (95% CI, 0.07%-0.16%; P < .0001) increase in QIA in the COPDGene cohort as well.
 

Smoking cessation

Smoking cessation is the obvious first step for patients with evidence of QIA progression but physicians can probably do more for these patients sooner, Dr. Ash said. “If we use heart disease as an analogy, we don’t want to start treating someone until they have a heart attack or are in heart failure, we start by checking their cholesterol and blood pressure and treating them with medications to prevent progression.”

Similarly, physicians need to start thinking about IPF and other lung diseases in the same way. For IPF, medications such as pirfenidone (Esbriet) and nintedanib (Ofev) do not reverse prior lung damage but they do slow disease progression and physicians need to initiate treatment before patients are short of breath, not after. Meantime, Dr. Ash advised physicians that, if they have a patient who is getting a CT scan for whatever reason, they should keep a close eye on whether or not patients have any of these interstitial changes and, if they do, then if the changes are getting worse.

“These patients are likely to be the ones who are going to develop IPF and who may benefit from ongoing imaging surveillance,” he said. And while clinicians may not yet be ready to use a quantitative tool at the bedside, “this tool – or one like it – is coming and we have to start thinking about how to incorporate these types of devices into our clinical practice.”
 

Temporal changes

Asked to comment on the findings, Surya Bhatt, MD, associate professor of medicine at the University of Alabama at Birmingham, said that the study advances the community’s understanding of the relationship between temporal changes in objectively measured interstitial lung abnormalities and several important clinical outcomes, including lung function decline and mortality. “Several risk factors for progression were also identified,” he noted.

“And these results make a case for initiating clinical trials to determine whether early treatment with existing antifibrotic medications in these high risk individuals can decrease the perpetuation of these permanent lung changes,” Dr. Bhatt said.

The COPDGene study was supported in part by contributions made by an industry advisory board. Dr. Ash was supported in part by Quantitative Imaging Solutions. Dr. Bhatt declared that he has receiving consulting fees or has service on advisory boards for Boehringer Ingelheim and Sanofi/Regeneron. He ha also received fee for CME from IntegrityCE.

Longitudinal progression of parenchymal changes on CT images — also referred to as quantitative interstitial abnormalities (QIA) – is independently associated with decreased lung function and an increased all-cause mortality risk, an analysis of two cohorts of ever-smokers indicates. And among the main risk factors for QIA progression is smoking.

“These abnormalities have gone by a few different names but fundamentally, they are high density findings of chest CT that in some cases represent early or subtle evidence of pulmonary fibrosis,” Samuel Ash, MD, MPH, assistant professor of medicine, Brigham and Women’s Hospital, Boston, told this news organization.

“I think this just adds to the huge list of reasons why people should quit smoking. So when I see someone with visual evidence of this type of change on their chest CT, I make sure to emphasize that while they don’t have interstitial lung disease [ILD] yet, these findings suggest they may be susceptible to lung injury from tobacco smoke and that if they don’t stop smoking now, they are at risk for a disease like interstitial pulmonary fibrosis [IPF] which is a highly morbid disease with a high mortality risk,” he added.

The study was published online in the journal CHEST.
 

Ever-smoking cohorts

Analysis of QIA progression on CT chest scans was carried out on participants from the Genetic Epidemiology of COPD (COPDGene) study as well as those from the Pittsburgh Lung Screening Study (PLuSS). COPDGene was a prospective cohort of over 10,300 ever-smokers with at least a 10–pack-year smoking history between the ages of 45 and 80. Participants underwent a series of tests including chest CT scans at baseline between 2006 and 2011 and again approximately 5 years later.

Patients with a postbronchodilator forced expiratory volume in 1 second (FEV₁) of 80% or more of predicted and a FEV₁-to-FVC (forced vital capacity) ratio of at least 0.7 were defined to have GOLD stage 0 disease while those with a postbronchodilator FEV₁ of 80% or less than predicted and a FEV₁-to-FVC ratio of at least 0.7 were defined to have preserved ratio impaired spirometry (PRISm) disease.

PLuSS involved 3,642 ever-smokers between the ages of 50 years and 79 years with at least a 12.5–pack-year history with no prior history of lung cancer. Participants again underwent a series of tests including a CT scan on visit 1 between 2002 and 2005 and then a second CT scan at a second visit almost 9 years later. “In the COPDGene cohort, 4,635 participants had complete clinical data, CT scans and spirometry from visits 1 and 2 for analysis,” the authors reported.

At visit 1 almost 48% of participants were current smokers and the mean pack-year history of the cohort was 41.9 years. The mean time between visits 1 and 2 was 5.6 years. Both the mean prebronchodilator FEV₁ as well as the mean FVC decreased between visits 1 and 2. For example, the mean prebronchodilator FEV₁ dropped from 2.2 liters to 2.0 liters between visits 1 and 2 while the mean prebronchodilator FVC decreased from 3.2 liters to 3.0 liters between the first and second visits.

In the PLuSS cohort, 1,307 participants had complete imaging and spirometry data available for visits 1 and 2 for analysis. The mean time between visits 1 and 2 was 8.6 years. Over 59% of the cohort were current smokers with a mean pack-year history of 65. Again, the mean prebronchodilator FEV1 and FVC both dropped between visit 1 and 2, as the authors note.

The mean prebronchodilator FEV1, for example, decreased from 2.5 liters to 2.1 liters between visits 1 and 2 while the mean prebronchodilator FVC dropped from 3.6 liters to 3.2 liters during the same interval. Looking at risk factors associated with QIA progression, investigators note that each additional year of baseline age was associated with a higher annual increase in QIA by 0.01% per year (95% confidence interval, 0.01%-0.02%; P < .001) in the COPDGene cohort and a 0.02% increase (95% CI, 0.01%-0.02%; P < .001) in the PLuSS cohort.

Female sex in turn was associated with a 0.07% per year (95% CI, 0.02%-0.12%; P = .003) higher increase in the QIA, compared with men in the COPDGene cohort and a 0.14% (95% CI, 0.02%-0.26%; P = .025) per year higher increase in the QIA in the PLuSS cohort. Current smoking status was only associated with a higher rate of QIA progression in the COPDGene cohort at a rate of 0.10% per year (95% CI, 0.06%-0.15%; P < .001).

Lastly, every copy of the minor allele of the MUIC5B promoter polymorphism was associated with a 0.12% per year (95% CI, 0.07%-0.16%; P < .0001) increase in QIA in the COPDGene cohort as well.
 

Smoking cessation

Smoking cessation is the obvious first step for patients with evidence of QIA progression but physicians can probably do more for these patients sooner, Dr. Ash said. “If we use heart disease as an analogy, we don’t want to start treating someone until they have a heart attack or are in heart failure, we start by checking their cholesterol and blood pressure and treating them with medications to prevent progression.”

Similarly, physicians need to start thinking about IPF and other lung diseases in the same way. For IPF, medications such as pirfenidone (Esbriet) and nintedanib (Ofev) do not reverse prior lung damage but they do slow disease progression and physicians need to initiate treatment before patients are short of breath, not after. Meantime, Dr. Ash advised physicians that, if they have a patient who is getting a CT scan for whatever reason, they should keep a close eye on whether or not patients have any of these interstitial changes and, if they do, then if the changes are getting worse.

“These patients are likely to be the ones who are going to develop IPF and who may benefit from ongoing imaging surveillance,” he said. And while clinicians may not yet be ready to use a quantitative tool at the bedside, “this tool – or one like it – is coming and we have to start thinking about how to incorporate these types of devices into our clinical practice.”
 

Temporal changes

Asked to comment on the findings, Surya Bhatt, MD, associate professor of medicine at the University of Alabama at Birmingham, said that the study advances the community’s understanding of the relationship between temporal changes in objectively measured interstitial lung abnormalities and several important clinical outcomes, including lung function decline and mortality. “Several risk factors for progression were also identified,” he noted.

“And these results make a case for initiating clinical trials to determine whether early treatment with existing antifibrotic medications in these high risk individuals can decrease the perpetuation of these permanent lung changes,” Dr. Bhatt said.

The COPDGene study was supported in part by contributions made by an industry advisory board. Dr. Ash was supported in part by Quantitative Imaging Solutions. Dr. Bhatt declared that he has receiving consulting fees or has service on advisory boards for Boehringer Ingelheim and Sanofi/Regeneron. He ha also received fee for CME from IntegrityCE.

An extensive new study shows that climate change can aggravate over half of known human pathogenic diseases. This comprehensive systematic review of the literature narrowed down 3,213 cases, linking 286 infectious diseases to specific climate change hazards. Of these, 58% were worsened, and only 9 conditions showed any benefit associated with environmental change.

The study was published online in Nature Climate Change. The complete list of cases, transmission pathways, and associated papers can be explored in detail – a remarkable, interactive data visualization.

To compile the data, investigators searched 10 keywords on the Global Infectious Disease and Epidemiology Network (GIDEON) and Center for Disease Control and Prevention databases. They then filled gaps by examining alternative names of the diseases, pathogens, and hazards.

Coauthor Tristan McKenzie, PhD, a postdoctoral researcher at the University of Gothenburg, Sweden, told this news organization: “If someone is interested in a certain pathway, it’s a beautiful starting point.” Or if someone wants to “do a modeling study and they want to focus on a specific area, the specific examples in the literature are already there” in the extensive database.

An early key finding is that warming and increased precipitation broadened the range of many pathogens through expansion of their habitat. This shift brings many pathogens closer to people. We have already seen vectors such as mosquitoes, ticks, fleas, birds, and several mammals spreading infections over a broader range. Examples are viruses (dengue, Chikungunya), bacteria (Lyme), protozoans (trypanosomes), and more. Warming has affected aquatic systems (for example, Vibrio) and higher altitudes and latitudes (malaria, dengue).

Pathogenic hazards are not just moving closer to people. People are also moving closer to the pathogenic hazards, with heat waves causing people to seek refuge with water activities, for example. This increases their exposure to pathogens, such as Vibrio, hepatitis, and water-borne gastroenteritis.

Some hazards, such as warming, can even make pathogens more virulent. Heat can upregulate Vibrio’s gene expression of proteins affecting transmission, adhesion, penetration, and host injury.

Heat and rainfall can increase stagnant water, enhancing mosquitoes’ breeding and growing grounds and enabling them to transmit many more infections.

People’s capacity to respond to climate hazards can also be impaired. For example, there is a reduced concentration of nutrients in crops under high CO2 levels, which can result in malnutrition. Lower crop yields can further fuel outbreaks of measles, cholera, or Cryptosporidium. Drought also likely forces people to drink contaminated water.

Among all this bad news, the authors found a small number of cases where climate hazards reduced the risk of infection. For example, droughts reduced the breeding grounds of mosquitoes, reducing the prevalence of malaria and chikungunya. But in other cases, the density of mosquitoes increased in some pools, causing an increased local risk of infection.

Naomi Hauser, MD, MPH, assistant clinical professor at UC Davis, Sacramento, told this news organization she was particularly impressed with the data visualization. “It really emphasizes the magnitude of what we’re dealing with. It makes you feel the weight of what they’re trying to represent,” she said.

On the other hand, Dr. Hauser said she would have liked “more emphasis on how the climate hazards interact with each other. It sort of made it sound like each of these climate hazards is in a vacuum – like when there’s floods, and that’s the problem. But there are a lot of other things ... like when we have warming and surface water temperature changes, it can also change the pH of the water and the salinity of the water, and those can also impact what we see with pathogens in the water.”

Dr. McKenzie explained one limitation: The study looked only at 10 keywords. So an example of a dust storm in Africa causing an increase in Vibrio in the United States could not be identified by this approach. “This also goes back to the scale of the problem, because we have something going on in the Sahara that’s impacting the East Coast of the United States,” he said. “And finding that link is not necessarily obvious – or at least not as obvious as [if] there [were] a hurricane and a bunch of people got sick from waterborne disease. So I think that really highlights the scale of this problem.”

Instead of looking at only one individual or group of pathogens, the study provided a much broader review of infections caused by an array of climate hazards. As Dr. McKenzie said, “no one’s actually done the work previously to really just try and get a comprehensive picture of what we might be dealing with. And so that was the goal for us.” The 58% estimate of diseases worsened by climate change is conservative, and, he says, “arguably, this is an even bigger problem than what we present.”

Dr. McKenzie concluded: “If we’re looking at the spread of some more serious or rare diseases in areas, to me then the answer is ... we need to be aggressively mitigating greenhouse gas emissions. Let’s start with the source.”

Dr. McKenzie and Dr. Hauser report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An extensive new study shows that climate change can aggravate over half of known human pathogenic diseases. This comprehensive systematic review of the literature narrowed down 3,213 cases, linking 286 infectious diseases to specific climate change hazards. Of these, 58% were worsened, and only 9 conditions showed any benefit associated with environmental change.

The study was published online in Nature Climate Change. The complete list of cases, transmission pathways, and associated papers can be explored in detail – a remarkable, interactive data visualization.

To compile the data, investigators searched 10 keywords on the Global Infectious Disease and Epidemiology Network (GIDEON) and Center for Disease Control and Prevention databases. They then filled gaps by examining alternative names of the diseases, pathogens, and hazards.

Coauthor Tristan McKenzie, PhD, a postdoctoral researcher at the University of Gothenburg, Sweden, told this news organization: “If someone is interested in a certain pathway, it’s a beautiful starting point.” Or if someone wants to “do a modeling study and they want to focus on a specific area, the specific examples in the literature are already there” in the extensive database.

An early key finding is that warming and increased precipitation broadened the range of many pathogens through expansion of their habitat. This shift brings many pathogens closer to people. We have already seen vectors such as mosquitoes, ticks, fleas, birds, and several mammals spreading infections over a broader range. Examples are viruses (dengue, Chikungunya), bacteria (Lyme), protozoans (trypanosomes), and more. Warming has affected aquatic systems (for example, Vibrio) and higher altitudes and latitudes (malaria, dengue).

Pathogenic hazards are not just moving closer to people. People are also moving closer to the pathogenic hazards, with heat waves causing people to seek refuge with water activities, for example. This increases their exposure to pathogens, such as Vibrio, hepatitis, and water-borne gastroenteritis.

Some hazards, such as warming, can even make pathogens more virulent. Heat can upregulate Vibrio’s gene expression of proteins affecting transmission, adhesion, penetration, and host injury.

Heat and rainfall can increase stagnant water, enhancing mosquitoes’ breeding and growing grounds and enabling them to transmit many more infections.

People’s capacity to respond to climate hazards can also be impaired. For example, there is a reduced concentration of nutrients in crops under high CO2 levels, which can result in malnutrition. Lower crop yields can further fuel outbreaks of measles, cholera, or Cryptosporidium. Drought also likely forces people to drink contaminated water.

Among all this bad news, the authors found a small number of cases where climate hazards reduced the risk of infection. For example, droughts reduced the breeding grounds of mosquitoes, reducing the prevalence of malaria and chikungunya. But in other cases, the density of mosquitoes increased in some pools, causing an increased local risk of infection.

Naomi Hauser, MD, MPH, assistant clinical professor at UC Davis, Sacramento, told this news organization she was particularly impressed with the data visualization. “It really emphasizes the magnitude of what we’re dealing with. It makes you feel the weight of what they’re trying to represent,” she said.

On the other hand, Dr. Hauser said she would have liked “more emphasis on how the climate hazards interact with each other. It sort of made it sound like each of these climate hazards is in a vacuum – like when there’s floods, and that’s the problem. But there are a lot of other things ... like when we have warming and surface water temperature changes, it can also change the pH of the water and the salinity of the water, and those can also impact what we see with pathogens in the water.”

Dr. McKenzie explained one limitation: The study looked only at 10 keywords. So an example of a dust storm in Africa causing an increase in Vibrio in the United States could not be identified by this approach. “This also goes back to the scale of the problem, because we have something going on in the Sahara that’s impacting the East Coast of the United States,” he said. “And finding that link is not necessarily obvious – or at least not as obvious as [if] there [were] a hurricane and a bunch of people got sick from waterborne disease. So I think that really highlights the scale of this problem.”

Instead of looking at only one individual or group of pathogens, the study provided a much broader review of infections caused by an array of climate hazards. As Dr. McKenzie said, “no one’s actually done the work previously to really just try and get a comprehensive picture of what we might be dealing with. And so that was the goal for us.” The 58% estimate of diseases worsened by climate change is conservative, and, he says, “arguably, this is an even bigger problem than what we present.”

Dr. McKenzie concluded: “If we’re looking at the spread of some more serious or rare diseases in areas, to me then the answer is ... we need to be aggressively mitigating greenhouse gas emissions. Let’s start with the source.”

Dr. McKenzie and Dr. Hauser report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An extensive new study shows that climate change can aggravate over half of known human pathogenic diseases. This comprehensive systematic review of the literature narrowed down 3,213 cases, linking 286 infectious diseases to specific climate change hazards. Of these, 58% were worsened, and only 9 conditions showed any benefit associated with environmental change.

The study was published online in Nature Climate Change. The complete list of cases, transmission pathways, and associated papers can be explored in detail – a remarkable, interactive data visualization.

To compile the data, investigators searched 10 keywords on the Global Infectious Disease and Epidemiology Network (GIDEON) and Center for Disease Control and Prevention databases. They then filled gaps by examining alternative names of the diseases, pathogens, and hazards.

Coauthor Tristan McKenzie, PhD, a postdoctoral researcher at the University of Gothenburg, Sweden, told this news organization: “If someone is interested in a certain pathway, it’s a beautiful starting point.” Or if someone wants to “do a modeling study and they want to focus on a specific area, the specific examples in the literature are already there” in the extensive database.

An early key finding is that warming and increased precipitation broadened the range of many pathogens through expansion of their habitat. This shift brings many pathogens closer to people. We have already seen vectors such as mosquitoes, ticks, fleas, birds, and several mammals spreading infections over a broader range. Examples are viruses (dengue, Chikungunya), bacteria (Lyme), protozoans (trypanosomes), and more. Warming has affected aquatic systems (for example, Vibrio) and higher altitudes and latitudes (malaria, dengue).

Pathogenic hazards are not just moving closer to people. People are also moving closer to the pathogenic hazards, with heat waves causing people to seek refuge with water activities, for example. This increases their exposure to pathogens, such as Vibrio, hepatitis, and water-borne gastroenteritis.

Some hazards, such as warming, can even make pathogens more virulent. Heat can upregulate Vibrio’s gene expression of proteins affecting transmission, adhesion, penetration, and host injury.

Heat and rainfall can increase stagnant water, enhancing mosquitoes’ breeding and growing grounds and enabling them to transmit many more infections.

People’s capacity to respond to climate hazards can also be impaired. For example, there is a reduced concentration of nutrients in crops under high CO2 levels, which can result in malnutrition. Lower crop yields can further fuel outbreaks of measles, cholera, or Cryptosporidium. Drought also likely forces people to drink contaminated water.

Among all this bad news, the authors found a small number of cases where climate hazards reduced the risk of infection. For example, droughts reduced the breeding grounds of mosquitoes, reducing the prevalence of malaria and chikungunya. But in other cases, the density of mosquitoes increased in some pools, causing an increased local risk of infection.

Naomi Hauser, MD, MPH, assistant clinical professor at UC Davis, Sacramento, told this news organization she was particularly impressed with the data visualization. “It really emphasizes the magnitude of what we’re dealing with. It makes you feel the weight of what they’re trying to represent,” she said.

On the other hand, Dr. Hauser said she would have liked “more emphasis on how the climate hazards interact with each other. It sort of made it sound like each of these climate hazards is in a vacuum – like when there’s floods, and that’s the problem. But there are a lot of other things ... like when we have warming and surface water temperature changes, it can also change the pH of the water and the salinity of the water, and those can also impact what we see with pathogens in the water.”

Dr. McKenzie explained one limitation: The study looked only at 10 keywords. So an example of a dust storm in Africa causing an increase in Vibrio in the United States could not be identified by this approach. “This also goes back to the scale of the problem, because we have something going on in the Sahara that’s impacting the East Coast of the United States,” he said. “And finding that link is not necessarily obvious – or at least not as obvious as [if] there [were] a hurricane and a bunch of people got sick from waterborne disease. So I think that really highlights the scale of this problem.”

Instead of looking at only one individual or group of pathogens, the study provided a much broader review of infections caused by an array of climate hazards. As Dr. McKenzie said, “no one’s actually done the work previously to really just try and get a comprehensive picture of what we might be dealing with. And so that was the goal for us.” The 58% estimate of diseases worsened by climate change is conservative, and, he says, “arguably, this is an even bigger problem than what we present.”

Dr. McKenzie concluded: “If we’re looking at the spread of some more serious or rare diseases in areas, to me then the answer is ... we need to be aggressively mitigating greenhouse gas emissions. Let’s start with the source.”

Dr. McKenzie and Dr. Hauser report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New cases of COVID-19 rose among children for the fourth consecutive week, but the size of the increase declined for the second consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.

Vaccine’s summer rollout gets lukewarm reception

As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.

That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.

[email protected]

New cases of COVID-19 rose among children for the fourth consecutive week, but the size of the increase declined for the second consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.

Vaccine’s summer rollout gets lukewarm reception

As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.

That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.

[email protected]

New cases of COVID-19 rose among children for the fourth consecutive week, but the size of the increase declined for the second consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.

Vaccine’s summer rollout gets lukewarm reception

As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.

That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.

[email protected]

The question of whether primary transoral surgery or radiation is a better treatment deescalation option for patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is still unanswered, despite the best efforts of investigators in the randomized phase 2 ORATOR2 trial.

Transoral surgery was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year, the study found.

The trial, begun in early 2018, was halted in late 2020 because of safety concerns after 2 of 31 patients randomized to surgery died from treatment-related causes.

But the story doesn’t end there, investigators and observers say.

In both trial arms, patients had good swallowing outcomes and other favorable quality-of-life measures at 1 year, and it’s too early to tell whether the transoral surgery (TOS) was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year, wrote investigators Daniel A. Palma, MD, from Western University in London, Ontario, and colleagues in JAMA Oncology.

Nonetheless, “the results of this randomized clinical trial suggest that a primary [surgery] approach was associated with an up-front risk of treatment-related mortality, and caution is warranted with this approach,” the investigators wrote.
 

Hard to interpret

“It’s challenging to do that study in Canada, frankly, and it’s hard to make much of it, with the trial being terminated early,” said Neil D. Gross, MD, a head and neck cancer surgeon-scientist with MD Anderson Cancer Center, Houston, in an interview.

Dr. Gross and Sewit Teckie, MD, system chief of radiation oncology at NYC Health and Hospitals, cowrote an editorial accompanying the ORATOR2 results that was published in JAMA Oncology.

“There’s a huge difference in the volume of transoral robotic surgery performed in the United States, compared with Canada – it’s night and day, and that’s due to the different kind of healthcare systems that we have,” Dr. Gross said.

As he and Dr. Teckie noted, the combined mortality rate for surgical patients in the multicenter ORATOR2 and the earlier ORATOR trial, which was not limited to patients with HPV-related cancers, was 3.6%.

In contrast, in the ECOG-ACRIN 3311 trial comparing standard radiation with reduced dose radiation following TOS in patients with intermediate-risk HPV-positive oropharynx cancer, there was only one death among 495 patients, for a mortality rate of 0.2%.

“In the United States, mortality after transoral robotic surgery compares favorably with nonsurgical treatment and is lowest at high-volume centers. ORATOR2 also mandated prophylactic tracheostomy, a practice rarely used in contemporary transoral surgery for low-risk HPV-related OPSCC,” the authors wrote.

In defense of surgery

In an interview posted on the JAMA Network website, ORATOR2 co-investigator Anthony C. Nichols, MD, from the department of otolaryngology, head and neck surgery at Western University, London, Ontario, said that despite the findings of ORATOR2, transoral surgery is a good option for patients with low-risk disease and favorable anatomy.

“When you even look at the subset of these early T-stage patients that have anatomy that’s favorable towards transoral surgery, they do better. Their burden of disease is smaller, there’s less extensive neck disease ... so what happens very frequently, including even in the discussion of ECOG-ACRIN 3311, is comparisons to these large cooperative group studies that include T3, T4 tumors that no one on the planet would think about removing transorally,” he said.

“Everyone focuses on the surgical stopping, but what we should also focus on is how outstanding the patients did in the RT arm in both these studies,” he added.

Dr. Nichols also noted that quality-of-life metrics for patients randomized to surgery are comparable with those of patients randomized to radiation and that swallowing outcomes with surgery may be superior.

“In our minds, I think the issue is resolved, and we’re just moving on to the next concept, and the debate will rage on,” he said.
 

ORATOR2 study methodology

The primary endpoint of the trial was OS, compared with historical controls, with secondary endpoints of PFS, quality of life, and toxicity.

A total of 30 patients were randomized to receive RT, and 31 to receive TOS and neck dissection, with adjuvant reduced-dose RT depending on pathologic findings.

At a median follow-up of 17 months, there were 3 deaths in the surgery arm, including the 2 previously mentioned patients who died from treatment-related causes at 0.7 and 4.3 months after randomization, and 1 patient who died from myocardial infarction at 8.5 months. As noted before, OS and PFS data were not mature at the time of study termination.

Quality of life and functional outcomes were generally similar between the trial arms, except for worse scores among patients randomized to TOS and neck dissection in subdomains of coughing and weight loss on the European Organisation for Research and Treatment of Cancer H&N35 scale.

The trial was supported by an Ontario Institute for Cancer Research clinician-scientist operating grant and Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers Fund. Dr. Nichols reported grants from Novartis Canada outside the submitted work. Dr. Gross reported grants and personal fees from Regeneron, personal fees from Sanofi-Genzyme, Intuitive Surgical, and DragonFly Therapeutics, as well as advisory board service for PDS Biotechnology, Shattuck Labs, and Sanofi-Genzyme outside the submitted work.

The question of whether primary transoral surgery or radiation is a better treatment deescalation option for patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is still unanswered, despite the best efforts of investigators in the randomized phase 2 ORATOR2 trial.

Transoral surgery was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year, the study found.

The trial, begun in early 2018, was halted in late 2020 because of safety concerns after 2 of 31 patients randomized to surgery died from treatment-related causes.

But the story doesn’t end there, investigators and observers say.

In both trial arms, patients had good swallowing outcomes and other favorable quality-of-life measures at 1 year, and it’s too early to tell whether the transoral surgery (TOS) was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year, wrote investigators Daniel A. Palma, MD, from Western University in London, Ontario, and colleagues in JAMA Oncology.

Nonetheless, “the results of this randomized clinical trial suggest that a primary [surgery] approach was associated with an up-front risk of treatment-related mortality, and caution is warranted with this approach,” the investigators wrote.
 

Hard to interpret

“It’s challenging to do that study in Canada, frankly, and it’s hard to make much of it, with the trial being terminated early,” said Neil D. Gross, MD, a head and neck cancer surgeon-scientist with MD Anderson Cancer Center, Houston, in an interview.

Dr. Gross and Sewit Teckie, MD, system chief of radiation oncology at NYC Health and Hospitals, cowrote an editorial accompanying the ORATOR2 results that was published in JAMA Oncology.

“There’s a huge difference in the volume of transoral robotic surgery performed in the United States, compared with Canada – it’s night and day, and that’s due to the different kind of healthcare systems that we have,” Dr. Gross said.

As he and Dr. Teckie noted, the combined mortality rate for surgical patients in the multicenter ORATOR2 and the earlier ORATOR trial, which was not limited to patients with HPV-related cancers, was 3.6%.

In contrast, in the ECOG-ACRIN 3311 trial comparing standard radiation with reduced dose radiation following TOS in patients with intermediate-risk HPV-positive oropharynx cancer, there was only one death among 495 patients, for a mortality rate of 0.2%.

“In the United States, mortality after transoral robotic surgery compares favorably with nonsurgical treatment and is lowest at high-volume centers. ORATOR2 also mandated prophylactic tracheostomy, a practice rarely used in contemporary transoral surgery for low-risk HPV-related OPSCC,” the authors wrote.

In defense of surgery

In an interview posted on the JAMA Network website, ORATOR2 co-investigator Anthony C. Nichols, MD, from the department of otolaryngology, head and neck surgery at Western University, London, Ontario, said that despite the findings of ORATOR2, transoral surgery is a good option for patients with low-risk disease and favorable anatomy.

“When you even look at the subset of these early T-stage patients that have anatomy that’s favorable towards transoral surgery, they do better. Their burden of disease is smaller, there’s less extensive neck disease ... so what happens very frequently, including even in the discussion of ECOG-ACRIN 3311, is comparisons to these large cooperative group studies that include T3, T4 tumors that no one on the planet would think about removing transorally,” he said.

“Everyone focuses on the surgical stopping, but what we should also focus on is how outstanding the patients did in the RT arm in both these studies,” he added.

Dr. Nichols also noted that quality-of-life metrics for patients randomized to surgery are comparable with those of patients randomized to radiation and that swallowing outcomes with surgery may be superior.

“In our minds, I think the issue is resolved, and we’re just moving on to the next concept, and the debate will rage on,” he said.
 

ORATOR2 study methodology

The primary endpoint of the trial was OS, compared with historical controls, with secondary endpoints of PFS, quality of life, and toxicity.

A total of 30 patients were randomized to receive RT, and 31 to receive TOS and neck dissection, with adjuvant reduced-dose RT depending on pathologic findings.

At a median follow-up of 17 months, there were 3 deaths in the surgery arm, including the 2 previously mentioned patients who died from treatment-related causes at 0.7 and 4.3 months after randomization, and 1 patient who died from myocardial infarction at 8.5 months. As noted before, OS and PFS data were not mature at the time of study termination.

Quality of life and functional outcomes were generally similar between the trial arms, except for worse scores among patients randomized to TOS and neck dissection in subdomains of coughing and weight loss on the European Organisation for Research and Treatment of Cancer H&N35 scale.

The trial was supported by an Ontario Institute for Cancer Research clinician-scientist operating grant and Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers Fund. Dr. Nichols reported grants from Novartis Canada outside the submitted work. Dr. Gross reported grants and personal fees from Regeneron, personal fees from Sanofi-Genzyme, Intuitive Surgical, and DragonFly Therapeutics, as well as advisory board service for PDS Biotechnology, Shattuck Labs, and Sanofi-Genzyme outside the submitted work.

The question of whether primary transoral surgery or radiation is a better treatment deescalation option for patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is still unanswered, despite the best efforts of investigators in the randomized phase 2 ORATOR2 trial.

Transoral surgery was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year, the study found.

The trial, begun in early 2018, was halted in late 2020 because of safety concerns after 2 of 31 patients randomized to surgery died from treatment-related causes.

But the story doesn’t end there, investigators and observers say.

In both trial arms, patients had good swallowing outcomes and other favorable quality-of-life measures at 1 year, and it’s too early to tell whether the transoral surgery (TOS) was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year, wrote investigators Daniel A. Palma, MD, from Western University in London, Ontario, and colleagues in JAMA Oncology.

Nonetheless, “the results of this randomized clinical trial suggest that a primary [surgery] approach was associated with an up-front risk of treatment-related mortality, and caution is warranted with this approach,” the investigators wrote.
 

Hard to interpret

“It’s challenging to do that study in Canada, frankly, and it’s hard to make much of it, with the trial being terminated early,” said Neil D. Gross, MD, a head and neck cancer surgeon-scientist with MD Anderson Cancer Center, Houston, in an interview.

Dr. Gross and Sewit Teckie, MD, system chief of radiation oncology at NYC Health and Hospitals, cowrote an editorial accompanying the ORATOR2 results that was published in JAMA Oncology.

“There’s a huge difference in the volume of transoral robotic surgery performed in the United States, compared with Canada – it’s night and day, and that’s due to the different kind of healthcare systems that we have,” Dr. Gross said.

As he and Dr. Teckie noted, the combined mortality rate for surgical patients in the multicenter ORATOR2 and the earlier ORATOR trial, which was not limited to patients with HPV-related cancers, was 3.6%.

In contrast, in the ECOG-ACRIN 3311 trial comparing standard radiation with reduced dose radiation following TOS in patients with intermediate-risk HPV-positive oropharynx cancer, there was only one death among 495 patients, for a mortality rate of 0.2%.

“In the United States, mortality after transoral robotic surgery compares favorably with nonsurgical treatment and is lowest at high-volume centers. ORATOR2 also mandated prophylactic tracheostomy, a practice rarely used in contemporary transoral surgery for low-risk HPV-related OPSCC,” the authors wrote.

In defense of surgery

In an interview posted on the JAMA Network website, ORATOR2 co-investigator Anthony C. Nichols, MD, from the department of otolaryngology, head and neck surgery at Western University, London, Ontario, said that despite the findings of ORATOR2, transoral surgery is a good option for patients with low-risk disease and favorable anatomy.

“When you even look at the subset of these early T-stage patients that have anatomy that’s favorable towards transoral surgery, they do better. Their burden of disease is smaller, there’s less extensive neck disease ... so what happens very frequently, including even in the discussion of ECOG-ACRIN 3311, is comparisons to these large cooperative group studies that include T3, T4 tumors that no one on the planet would think about removing transorally,” he said.

“Everyone focuses on the surgical stopping, but what we should also focus on is how outstanding the patients did in the RT arm in both these studies,” he added.

Dr. Nichols also noted that quality-of-life metrics for patients randomized to surgery are comparable with those of patients randomized to radiation and that swallowing outcomes with surgery may be superior.

“In our minds, I think the issue is resolved, and we’re just moving on to the next concept, and the debate will rage on,” he said.
 

ORATOR2 study methodology

The primary endpoint of the trial was OS, compared with historical controls, with secondary endpoints of PFS, quality of life, and toxicity.

A total of 30 patients were randomized to receive RT, and 31 to receive TOS and neck dissection, with adjuvant reduced-dose RT depending on pathologic findings.

At a median follow-up of 17 months, there were 3 deaths in the surgery arm, including the 2 previously mentioned patients who died from treatment-related causes at 0.7 and 4.3 months after randomization, and 1 patient who died from myocardial infarction at 8.5 months. As noted before, OS and PFS data were not mature at the time of study termination.

Quality of life and functional outcomes were generally similar between the trial arms, except for worse scores among patients randomized to TOS and neck dissection in subdomains of coughing and weight loss on the European Organisation for Research and Treatment of Cancer H&N35 scale.

The trial was supported by an Ontario Institute for Cancer Research clinician-scientist operating grant and Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers Fund. Dr. Nichols reported grants from Novartis Canada outside the submitted work. Dr. Gross reported grants and personal fees from Regeneron, personal fees from Sanofi-Genzyme, Intuitive Surgical, and DragonFly Therapeutics, as well as advisory board service for PDS Biotechnology, Shattuck Labs, and Sanofi-Genzyme outside the submitted work.

Most patients with drug-resistant epilepsy should receive a referral for a surgical evaluation as soon as it’s clear their disease is drug resistant, according to expert consensus recommendations from the International League Against Epilepsy (ILAE) published in the journal Epilepsia.

Comprehensive epilepsy care

Such a referral is not ”a commitment to undergo brain surgery,” wrote the authors of the new recommendations study, but surgical evaluations offer patients an opportunity to learn about the range of therapies available to them and to have their diagnosis verified, as well as learning about the cause and type of epilepsy they have, even if they ultimately do not pursue surgery.

”In fact, most patients with drug-resistant epilepsy do not end up undergoing surgery after referral, but still benefit from comprehensive epilepsy care improving quality of life and lowering mortality,” wrote lead author Lara Jehi, MD, professor of neurology and epilepsy specialist at Cleveland Clinic, and her colleagues. “A better characterization of the epilepsy can also help optimize medical therapy and address somatic, cognitive, behavioral, and psychiatric comorbidities.”
 

Is the diagnosis correct?

They noted that about one-third of patients referred to epilepsy centers with an apparent diagnosis of drug-resistant epilepsy actually have psychogenic nonepileptic seizures (PNES) – not epilepsy – and an early, accurate diagnosis of PNES can ensure they receive psychotherapy, stop taking antiseizure medications, and have better outcomes.

“These recommendations are necessary, as the delay to surgery and the overall underutilization of surgery have not improved much over the last 20 years,” said Selim R. Benbadis, MD, professor of neurology and director of the comprehensive epilepsy program at the University of South Florida and Tampa General Hospital. “Comprehensive epilepsy centers offer more than surgery, including correct and precise diagnosis, drug options, three [Food and Drug Administration]–approved neurostimulation options, and more,” said Dr. Benbadis, who was not involved in the development of these recommendations.
 

Consensus recommendations

On behalf of the the ILAE’s Surgical Therapies Commission, the authors used the Delphi consensus process to develop expert consensus recommendations on when to refer patients with epilepsy to surgery. They conducted three Delphi rounds on 51 clinical scenarios with 61 epileptologists (38% of participants), epilepsy neurosurgeons (34%), neurologists (23%), neuropsychiatrists (2%), and neuropsychologists (3%) from 28 countries. Most of clinicians focused on adults (39%) or adults and children (41%) while 20% focused only on pediatric epilepsy.

The physicians involved had a median 22 years of practice and represented all six ILAE regions: 30% from North America, 28% from Europe, 18% from Asia/Oceania, 13% from Latin America, 7% from the Eastern Mediterranean, and 4% from Africa.

The result of these rounds were three key recommendations arising from the consensus of experts consulted. First, every patient up to 70 years old who has drug-resistant epilepsy should be offered the option of a surgical evaluation as soon as it’s apparent that they have drug resistance. The option for surgical evaluation should be provided independent of their sex or socioeconomic status and regardless of how long they have had epilepsy, their seizure type, their epilepsy type, localization, and their comorbidities, ”including severe psychiatric comorbidity like psychogenic nonepileptic seizures (PNES) or substance abuse if patients are cooperative with management,” the authors wrote.

”Resective surgery can improve quality of life and cognitive outcomes and is the only treatment demonstrated to improve survival and reverse excess mortality attributed to drug-resistant epilepsy,” the authors wrote. Evidence supports that surgical evaluation is the most cost-effective approach to treating drug-resistant epilepsy, they added. Yet, it still takes about 20 years with epilepsy before an adult patient might be referred, ”and the neurology community remains ambivalent due to ongoing barriers and misconceptions about epilepsy surgery,” they wrote.

The second recommendation is to consider a surgical referral for older patients with drug-resistant epilepsy who have no surgical contraindication. Physicians can also consider a referral for patients of any age who are seizure free while taking one to two antiseizure drugs but who have a brain lesion in the noneloquent cortex.

The third recommendation is not to offer surgery if a patient has an active substance dependency and is not cooperative with management.

“Although there is some evidence that seizure outcomes are no different in individuals with active substance use disorder who have epilepsy surgery, the literature suggests increased perioperative surgical and anesthetic risk in this cohort,” the authors wrote. ”Patients with active substance abuse are more likely to be nonadherent with their seizure medications, and to leave the hospital against medical advice.”

One area where the participants did not reach consensus was regarding whether to refer patients who did not become seizure-free after trying just one “tolerated and appropriately chosen” antiseizure medication. Half (49%) said they would be unlikely to refer or would never refer that patient while 44% said they would likely or always refer them, and 7% weren’t sure.
 

The ‘next level’ of epilepsy care

“Similar recommendations have been published before, by the National Association of Epilepsy Centers, more than once, and have not changed the referral patterns,” Dr. Benbadis said. “They are not implemented by the average general neurologist.” While there are many reasons for this, one with a relativity simple fix is to adjust the language doctors use to when talking with patients about getting an evaluation, Dr. Benbadis said. ”The key is to rephrase: Instead of referrals ‘for surgery,’ which can be scary to many neurologists and patients, we should use more general terms, like referrals for the ‘next level of care by epilepsy specialists,’ ” said Dr. Benbadis, who advocated for this change in terminology in a 2019 editorial. Such language is less frightening and can ease patients’ concerns about going to an epilepsy center where they can learn about more options than just surgery.

Further, surgical options have expanded in recent years, including the development of laser interstitial thermal therapy and neuromodulation. “Identifying candidacy for any of these approaches starts with a surgical referral, so a timely evaluation is key,” the authors wrote.
 

Referral delays persist

Despite the strong evidence for timely referrals, delays have persisted for decades, said Dr. Benbadis, echoing what the authors describe. ”Despite the results of two randomized controlled trials showing that surgery for temporal lobe epilepsy in adults, and resective surgery in children, is superior to continued antiseizure medications both in terms of seizure freedom and improved quality of life, the mean epilepsy duration to temporal lobe resection has persisted at over 20 years,” the authors wrote. ”Although drug resistance is reached with a mean latency of 9 years in epilepsy surgery candidates, these patients have experienced a decade of unabating seizures with detrimental effects including cognitive and psychiatric comorbidities, poor psychosocial outcomes, potential injuries, and risk of death.”

Surgery is not a ‘dangerous last resort’

The authors point out a variety of likely reasons for these delays, including patients experiencing temporary remissions with a new drug, lack of adequate health care access, overestimating surgery risks, and underestimating the seriousness and risk of death from ongoing seizures.

Dr. Benbadis agreed, referring to a “combination of lack of knowledge and unrealistic views about surgery outcomes and complications.” Patients and their neurologists think surgery is a “dangerous last resort, fraught with complications, and they don’t know the outcome, so it’s mainly that they are not very well-educated about epilepsy surgery,” he said. Complacency about a patient’s infrequent seizures plays a role as well, he added. “Their patient is having one seizure every 2 months, and they might say, ‘well, that’s okay, that’s not that bad,’ but it is when we can cure it.”

Similar factors are barriers to epilepsy surgery: “lack of knowledge or misconceptions about surgical risks, negative behaviors, or cultural issues and access issues.”

Another major barrier, both within neurology and throughout medicine in general, is that large academic centers that accept referrals, including epilepsy centers, have poor communication, follow-up, and scheduling, Dr. Benbadis said.

The authors provided a table with suggestions on potential solutions to those barriers, including identifying online resources to help doctors identify possible surgery candidates, such as www.toolsforepilepsy.com, and a range of educational resources. Ways to improve access and cost include mobile clinics, telehealth, coordinating with an epilepsy organization, and employing a multidisciplinary team that includes a social worker to help with support such as transportation and health insurance.

Most patients with drug-resistant epilepsy should receive a referral for a surgical evaluation as soon as it’s clear their disease is drug resistant, according to expert consensus recommendations from the International League Against Epilepsy (ILAE) published in the journal Epilepsia.

Comprehensive epilepsy care

Such a referral is not ”a commitment to undergo brain surgery,” wrote the authors of the new recommendations study, but surgical evaluations offer patients an opportunity to learn about the range of therapies available to them and to have their diagnosis verified, as well as learning about the cause and type of epilepsy they have, even if they ultimately do not pursue surgery.

”In fact, most patients with drug-resistant epilepsy do not end up undergoing surgery after referral, but still benefit from comprehensive epilepsy care improving quality of life and lowering mortality,” wrote lead author Lara Jehi, MD, professor of neurology and epilepsy specialist at Cleveland Clinic, and her colleagues. “A better characterization of the epilepsy can also help optimize medical therapy and address somatic, cognitive, behavioral, and psychiatric comorbidities.”
 

Is the diagnosis correct?

They noted that about one-third of patients referred to epilepsy centers with an apparent diagnosis of drug-resistant epilepsy actually have psychogenic nonepileptic seizures (PNES) – not epilepsy – and an early, accurate diagnosis of PNES can ensure they receive psychotherapy, stop taking antiseizure medications, and have better outcomes.

“These recommendations are necessary, as the delay to surgery and the overall underutilization of surgery have not improved much over the last 20 years,” said Selim R. Benbadis, MD, professor of neurology and director of the comprehensive epilepsy program at the University of South Florida and Tampa General Hospital. “Comprehensive epilepsy centers offer more than surgery, including correct and precise diagnosis, drug options, three [Food and Drug Administration]–approved neurostimulation options, and more,” said Dr. Benbadis, who was not involved in the development of these recommendations.
 

Consensus recommendations

On behalf of the the ILAE’s Surgical Therapies Commission, the authors used the Delphi consensus process to develop expert consensus recommendations on when to refer patients with epilepsy to surgery. They conducted three Delphi rounds on 51 clinical scenarios with 61 epileptologists (38% of participants), epilepsy neurosurgeons (34%), neurologists (23%), neuropsychiatrists (2%), and neuropsychologists (3%) from 28 countries. Most of clinicians focused on adults (39%) or adults and children (41%) while 20% focused only on pediatric epilepsy.

The physicians involved had a median 22 years of practice and represented all six ILAE regions: 30% from North America, 28% from Europe, 18% from Asia/Oceania, 13% from Latin America, 7% from the Eastern Mediterranean, and 4% from Africa.

The result of these rounds were three key recommendations arising from the consensus of experts consulted. First, every patient up to 70 years old who has drug-resistant epilepsy should be offered the option of a surgical evaluation as soon as it’s apparent that they have drug resistance. The option for surgical evaluation should be provided independent of their sex or socioeconomic status and regardless of how long they have had epilepsy, their seizure type, their epilepsy type, localization, and their comorbidities, ”including severe psychiatric comorbidity like psychogenic nonepileptic seizures (PNES) or substance abuse if patients are cooperative with management,” the authors wrote.

”Resective surgery can improve quality of life and cognitive outcomes and is the only treatment demonstrated to improve survival and reverse excess mortality attributed to drug-resistant epilepsy,” the authors wrote. Evidence supports that surgical evaluation is the most cost-effective approach to treating drug-resistant epilepsy, they added. Yet, it still takes about 20 years with epilepsy before an adult patient might be referred, ”and the neurology community remains ambivalent due to ongoing barriers and misconceptions about epilepsy surgery,” they wrote.

The second recommendation is to consider a surgical referral for older patients with drug-resistant epilepsy who have no surgical contraindication. Physicians can also consider a referral for patients of any age who are seizure free while taking one to two antiseizure drugs but who have a brain lesion in the noneloquent cortex.

The third recommendation is not to offer surgery if a patient has an active substance dependency and is not cooperative with management.

“Although there is some evidence that seizure outcomes are no different in individuals with active substance use disorder who have epilepsy surgery, the literature suggests increased perioperative surgical and anesthetic risk in this cohort,” the authors wrote. ”Patients with active substance abuse are more likely to be nonadherent with their seizure medications, and to leave the hospital against medical advice.”

One area where the participants did not reach consensus was regarding whether to refer patients who did not become seizure-free after trying just one “tolerated and appropriately chosen” antiseizure medication. Half (49%) said they would be unlikely to refer or would never refer that patient while 44% said they would likely or always refer them, and 7% weren’t sure.
 

The ‘next level’ of epilepsy care

“Similar recommendations have been published before, by the National Association of Epilepsy Centers, more than once, and have not changed the referral patterns,” Dr. Benbadis said. “They are not implemented by the average general neurologist.” While there are many reasons for this, one with a relativity simple fix is to adjust the language doctors use to when talking with patients about getting an evaluation, Dr. Benbadis said. ”The key is to rephrase: Instead of referrals ‘for surgery,’ which can be scary to many neurologists and patients, we should use more general terms, like referrals for the ‘next level of care by epilepsy specialists,’ ” said Dr. Benbadis, who advocated for this change in terminology in a 2019 editorial. Such language is less frightening and can ease patients’ concerns about going to an epilepsy center where they can learn about more options than just surgery.

Further, surgical options have expanded in recent years, including the development of laser interstitial thermal therapy and neuromodulation. “Identifying candidacy for any of these approaches starts with a surgical referral, so a timely evaluation is key,” the authors wrote.
 

Referral delays persist

Despite the strong evidence for timely referrals, delays have persisted for decades, said Dr. Benbadis, echoing what the authors describe. ”Despite the results of two randomized controlled trials showing that surgery for temporal lobe epilepsy in adults, and resective surgery in children, is superior to continued antiseizure medications both in terms of seizure freedom and improved quality of life, the mean epilepsy duration to temporal lobe resection has persisted at over 20 years,” the authors wrote. ”Although drug resistance is reached with a mean latency of 9 years in epilepsy surgery candidates, these patients have experienced a decade of unabating seizures with detrimental effects including cognitive and psychiatric comorbidities, poor psychosocial outcomes, potential injuries, and risk of death.”

Surgery is not a ‘dangerous last resort’

The authors point out a variety of likely reasons for these delays, including patients experiencing temporary remissions with a new drug, lack of adequate health care access, overestimating surgery risks, and underestimating the seriousness and risk of death from ongoing seizures.

Dr. Benbadis agreed, referring to a “combination of lack of knowledge and unrealistic views about surgery outcomes and complications.” Patients and their neurologists think surgery is a “dangerous last resort, fraught with complications, and they don’t know the outcome, so it’s mainly that they are not very well-educated about epilepsy surgery,” he said. Complacency about a patient’s infrequent seizures plays a role as well, he added. “Their patient is having one seizure every 2 months, and they might say, ‘well, that’s okay, that’s not that bad,’ but it is when we can cure it.”

Similar factors are barriers to epilepsy surgery: “lack of knowledge or misconceptions about surgical risks, negative behaviors, or cultural issues and access issues.”

Another major barrier, both within neurology and throughout medicine in general, is that large academic centers that accept referrals, including epilepsy centers, have poor communication, follow-up, and scheduling, Dr. Benbadis said.

The authors provided a table with suggestions on potential solutions to those barriers, including identifying online resources to help doctors identify possible surgery candidates, such as www.toolsforepilepsy.com, and a range of educational resources. Ways to improve access and cost include mobile clinics, telehealth, coordinating with an epilepsy organization, and employing a multidisciplinary team that includes a social worker to help with support such as transportation and health insurance.

Most patients with drug-resistant epilepsy should receive a referral for a surgical evaluation as soon as it’s clear their disease is drug resistant, according to expert consensus recommendations from the International League Against Epilepsy (ILAE) published in the journal Epilepsia.

Comprehensive epilepsy care

Such a referral is not ”a commitment to undergo brain surgery,” wrote the authors of the new recommendations study, but surgical evaluations offer patients an opportunity to learn about the range of therapies available to them and to have their diagnosis verified, as well as learning about the cause and type of epilepsy they have, even if they ultimately do not pursue surgery.

”In fact, most patients with drug-resistant epilepsy do not end up undergoing surgery after referral, but still benefit from comprehensive epilepsy care improving quality of life and lowering mortality,” wrote lead author Lara Jehi, MD, professor of neurology and epilepsy specialist at Cleveland Clinic, and her colleagues. “A better characterization of the epilepsy can also help optimize medical therapy and address somatic, cognitive, behavioral, and psychiatric comorbidities.”
 

Is the diagnosis correct?

They noted that about one-third of patients referred to epilepsy centers with an apparent diagnosis of drug-resistant epilepsy actually have psychogenic nonepileptic seizures (PNES) – not epilepsy – and an early, accurate diagnosis of PNES can ensure they receive psychotherapy, stop taking antiseizure medications, and have better outcomes.

“These recommendations are necessary, as the delay to surgery and the overall underutilization of surgery have not improved much over the last 20 years,” said Selim R. Benbadis, MD, professor of neurology and director of the comprehensive epilepsy program at the University of South Florida and Tampa General Hospital. “Comprehensive epilepsy centers offer more than surgery, including correct and precise diagnosis, drug options, three [Food and Drug Administration]–approved neurostimulation options, and more,” said Dr. Benbadis, who was not involved in the development of these recommendations.
 

Consensus recommendations

On behalf of the the ILAE’s Surgical Therapies Commission, the authors used the Delphi consensus process to develop expert consensus recommendations on when to refer patients with epilepsy to surgery. They conducted three Delphi rounds on 51 clinical scenarios with 61 epileptologists (38% of participants), epilepsy neurosurgeons (34%), neurologists (23%), neuropsychiatrists (2%), and neuropsychologists (3%) from 28 countries. Most of clinicians focused on adults (39%) or adults and children (41%) while 20% focused only on pediatric epilepsy.

The physicians involved had a median 22 years of practice and represented all six ILAE regions: 30% from North America, 28% from Europe, 18% from Asia/Oceania, 13% from Latin America, 7% from the Eastern Mediterranean, and 4% from Africa.

The result of these rounds were three key recommendations arising from the consensus of experts consulted. First, every patient up to 70 years old who has drug-resistant epilepsy should be offered the option of a surgical evaluation as soon as it’s apparent that they have drug resistance. The option for surgical evaluation should be provided independent of their sex or socioeconomic status and regardless of how long they have had epilepsy, their seizure type, their epilepsy type, localization, and their comorbidities, ”including severe psychiatric comorbidity like psychogenic nonepileptic seizures (PNES) or substance abuse if patients are cooperative with management,” the authors wrote.

”Resective surgery can improve quality of life and cognitive outcomes and is the only treatment demonstrated to improve survival and reverse excess mortality attributed to drug-resistant epilepsy,” the authors wrote. Evidence supports that surgical evaluation is the most cost-effective approach to treating drug-resistant epilepsy, they added. Yet, it still takes about 20 years with epilepsy before an adult patient might be referred, ”and the neurology community remains ambivalent due to ongoing barriers and misconceptions about epilepsy surgery,” they wrote.

The second recommendation is to consider a surgical referral for older patients with drug-resistant epilepsy who have no surgical contraindication. Physicians can also consider a referral for patients of any age who are seizure free while taking one to two antiseizure drugs but who have a brain lesion in the noneloquent cortex.

The third recommendation is not to offer surgery if a patient has an active substance dependency and is not cooperative with management.

“Although there is some evidence that seizure outcomes are no different in individuals with active substance use disorder who have epilepsy surgery, the literature suggests increased perioperative surgical and anesthetic risk in this cohort,” the authors wrote. ”Patients with active substance abuse are more likely to be nonadherent with their seizure medications, and to leave the hospital against medical advice.”

One area where the participants did not reach consensus was regarding whether to refer patients who did not become seizure-free after trying just one “tolerated and appropriately chosen” antiseizure medication. Half (49%) said they would be unlikely to refer or would never refer that patient while 44% said they would likely or always refer them, and 7% weren’t sure.
 

The ‘next level’ of epilepsy care

“Similar recommendations have been published before, by the National Association of Epilepsy Centers, more than once, and have not changed the referral patterns,” Dr. Benbadis said. “They are not implemented by the average general neurologist.” While there are many reasons for this, one with a relativity simple fix is to adjust the language doctors use to when talking with patients about getting an evaluation, Dr. Benbadis said. ”The key is to rephrase: Instead of referrals ‘for surgery,’ which can be scary to many neurologists and patients, we should use more general terms, like referrals for the ‘next level of care by epilepsy specialists,’ ” said Dr. Benbadis, who advocated for this change in terminology in a 2019 editorial. Such language is less frightening and can ease patients’ concerns about going to an epilepsy center where they can learn about more options than just surgery.

Further, surgical options have expanded in recent years, including the development of laser interstitial thermal therapy and neuromodulation. “Identifying candidacy for any of these approaches starts with a surgical referral, so a timely evaluation is key,” the authors wrote.
 

Referral delays persist

Despite the strong evidence for timely referrals, delays have persisted for decades, said Dr. Benbadis, echoing what the authors describe. ”Despite the results of two randomized controlled trials showing that surgery for temporal lobe epilepsy in adults, and resective surgery in children, is superior to continued antiseizure medications both in terms of seizure freedom and improved quality of life, the mean epilepsy duration to temporal lobe resection has persisted at over 20 years,” the authors wrote. ”Although drug resistance is reached with a mean latency of 9 years in epilepsy surgery candidates, these patients have experienced a decade of unabating seizures with detrimental effects including cognitive and psychiatric comorbidities, poor psychosocial outcomes, potential injuries, and risk of death.”

Surgery is not a ‘dangerous last resort’

The authors point out a variety of likely reasons for these delays, including patients experiencing temporary remissions with a new drug, lack of adequate health care access, overestimating surgery risks, and underestimating the seriousness and risk of death from ongoing seizures.

Dr. Benbadis agreed, referring to a “combination of lack of knowledge and unrealistic views about surgery outcomes and complications.” Patients and their neurologists think surgery is a “dangerous last resort, fraught with complications, and they don’t know the outcome, so it’s mainly that they are not very well-educated about epilepsy surgery,” he said. Complacency about a patient’s infrequent seizures plays a role as well, he added. “Their patient is having one seizure every 2 months, and they might say, ‘well, that’s okay, that’s not that bad,’ but it is when we can cure it.”

Similar factors are barriers to epilepsy surgery: “lack of knowledge or misconceptions about surgical risks, negative behaviors, or cultural issues and access issues.”

Another major barrier, both within neurology and throughout medicine in general, is that large academic centers that accept referrals, including epilepsy centers, have poor communication, follow-up, and scheduling, Dr. Benbadis said.

The authors provided a table with suggestions on potential solutions to those barriers, including identifying online resources to help doctors identify possible surgery candidates, such as www.toolsforepilepsy.com, and a range of educational resources. Ways to improve access and cost include mobile clinics, telehealth, coordinating with an epilepsy organization, and employing a multidisciplinary team that includes a social worker to help with support such as transportation and health insurance.

Individuals of nonwhite race/ethnicity are underrepresented in cosmetic clinical trials. Individuals of nonwhite race/ethnicity are not underrepresented in cosmetic clinical trials, according to a recent literature review. The explanation for those contradictory conclusions comes down to money, or, more specifically, the source of the money.

Among the cosmetic studies funded by industry, non-Whites represented about 25% of the patient populations. That proportion, however, rose to 62% for studies that were funded by universities/governments or had no funding source reported, Lisa Akintilo, MD, and associates said in their review.

“Lack of inclusion of diverse patient populations is both a medical and moral issue as conclusions of such homogeneous studies may not be generalizable. In the realm of cosmetic dermatology, diverse research cohorts are needed to identify potential disparities in therapies for cosmetic concerns and fully investigate effective treatments for all,” wrote Dr. Akintilo of New York University and coauthors.

Data from the U.S. Census show that non-Hispanic Whites made up 60% of the population in 2019, with that proportion falling to about 50% by 2045, the investigators noted. A report from the American Society of Plastic Surgeons showed that about 34% of cosmetic patients identified as skin of color in 2020.

The availability of data was an issue in the review of the literature from 1990 to 2020, as 55% of the 318 randomized controlled trials that were reviewed did not include any information on racial/ethnic diversity and the other 143 studies offered only enough to determine White/non-White status, they explained.

That limitation meant that those 143 studies had to form the basis of the funding analysis, which also indicated that the studies with funding outside of industry were significantly more likely (odds ratio, 7.8) to have more than 50% non-White participants, compared with the industry-funded trials. The projects with industry backing, however, had a larger mean sample size than did those without: 139 vs. 81, Dr. Akintilo and associates said.

“The protocols of cosmetic trials should be questioned, as many target Caucasian‐centric treatment goals that may not be in alignment with the goals of skin of color patients,” they wrote. “It is important for cosmetic providers to recognize the well-established anatomical variations between different races and ethnicities and how they can inform desired cosmetic procedures.”

The investigators said that they had no conflicts of interest.

[email protected]

Individuals of nonwhite race/ethnicity are underrepresented in cosmetic clinical trials. Individuals of nonwhite race/ethnicity are not underrepresented in cosmetic clinical trials, according to a recent literature review. The explanation for those contradictory conclusions comes down to money, or, more specifically, the source of the money.

Among the cosmetic studies funded by industry, non-Whites represented about 25% of the patient populations. That proportion, however, rose to 62% for studies that were funded by universities/governments or had no funding source reported, Lisa Akintilo, MD, and associates said in their review.

“Lack of inclusion of diverse patient populations is both a medical and moral issue as conclusions of such homogeneous studies may not be generalizable. In the realm of cosmetic dermatology, diverse research cohorts are needed to identify potential disparities in therapies for cosmetic concerns and fully investigate effective treatments for all,” wrote Dr. Akintilo of New York University and coauthors.

Data from the U.S. Census show that non-Hispanic Whites made up 60% of the population in 2019, with that proportion falling to about 50% by 2045, the investigators noted. A report from the American Society of Plastic Surgeons showed that about 34% of cosmetic patients identified as skin of color in 2020.

The availability of data was an issue in the review of the literature from 1990 to 2020, as 55% of the 318 randomized controlled trials that were reviewed did not include any information on racial/ethnic diversity and the other 143 studies offered only enough to determine White/non-White status, they explained.

That limitation meant that those 143 studies had to form the basis of the funding analysis, which also indicated that the studies with funding outside of industry were significantly more likely (odds ratio, 7.8) to have more than 50% non-White participants, compared with the industry-funded trials. The projects with industry backing, however, had a larger mean sample size than did those without: 139 vs. 81, Dr. Akintilo and associates said.

“The protocols of cosmetic trials should be questioned, as many target Caucasian‐centric treatment goals that may not be in alignment with the goals of skin of color patients,” they wrote. “It is important for cosmetic providers to recognize the well-established anatomical variations between different races and ethnicities and how they can inform desired cosmetic procedures.”

The investigators said that they had no conflicts of interest.

[email protected]

Individuals of nonwhite race/ethnicity are underrepresented in cosmetic clinical trials. Individuals of nonwhite race/ethnicity are not underrepresented in cosmetic clinical trials, according to a recent literature review. The explanation for those contradictory conclusions comes down to money, or, more specifically, the source of the money.

Among the cosmetic studies funded by industry, non-Whites represented about 25% of the patient populations. That proportion, however, rose to 62% for studies that were funded by universities/governments or had no funding source reported, Lisa Akintilo, MD, and associates said in their review.

“Lack of inclusion of diverse patient populations is both a medical and moral issue as conclusions of such homogeneous studies may not be generalizable. In the realm of cosmetic dermatology, diverse research cohorts are needed to identify potential disparities in therapies for cosmetic concerns and fully investigate effective treatments for all,” wrote Dr. Akintilo of New York University and coauthors.

Data from the U.S. Census show that non-Hispanic Whites made up 60% of the population in 2019, with that proportion falling to about 50% by 2045, the investigators noted. A report from the American Society of Plastic Surgeons showed that about 34% of cosmetic patients identified as skin of color in 2020.

The availability of data was an issue in the review of the literature from 1990 to 2020, as 55% of the 318 randomized controlled trials that were reviewed did not include any information on racial/ethnic diversity and the other 143 studies offered only enough to determine White/non-White status, they explained.

That limitation meant that those 143 studies had to form the basis of the funding analysis, which also indicated that the studies with funding outside of industry were significantly more likely (odds ratio, 7.8) to have more than 50% non-White participants, compared with the industry-funded trials. The projects with industry backing, however, had a larger mean sample size than did those without: 139 vs. 81, Dr. Akintilo and associates said.

“The protocols of cosmetic trials should be questioned, as many target Caucasian‐centric treatment goals that may not be in alignment with the goals of skin of color patients,” they wrote. “It is important for cosmetic providers to recognize the well-established anatomical variations between different races and ethnicities and how they can inform desired cosmetic procedures.”

The investigators said that they had no conflicts of interest.

[email protected]

About half of women with an asymptomatic low-lying placenta in the third trimester and an internal os distance of 11-20 mm can have a vaginal birth after 35 weeks without any higher risk of severe complications than if they had undergone elective cesarean delivery, a new study indicates.

The retrospective analysis of 128,233 births between 2007 and 2012 at six hospitals in France showed that of the 171 women (0.13%) with low-lying placenta, 70 underwent a trial of labor, and 101 had an elective cesarean delivery. The vaginal delivery rate was 50.0% in the group of 38 women with an internal os distance of 11-20 mm, and 18.5% among 27 women with an internal os distance of 1-10 mm.

Similar rates of severe postpartum hemorrhage (PPH) were observed whether the patient opted for a trial of labor or for elective cesarean delivery (22.9% vs. 23.0%), regardless of maternal age, prepregnancy body mass index, nulliparity, and previous cesarean delivery. Rates of severe maternal and neonatal morbidity were 2.9% vs. 2.0%, and 12.9% vs. 9.9%, respectively, both nonsignificantly different, the study showed.

These findings confirm results from an earlier study and could reduce the incidence of unnecessary cesarean deliveries in women with low-lying placenta, said researchers led by Loïc Sentilhes, MD, PhD, of the department of obstetrics and gynecology at Bordeaux (France) University Hospital Center.

“Our results support a policy of offering a trial of labor to women with low-lying placenta at or after 35 weeks of gestation and a distance of 11-20 mm between the placental edge and the internal os on ultrasonography,” they wrote in Obstetrics & Gynecology.

Although an internal os distance of 1-10 mm did not increase the incidence of severe PPH or other severe maternal morbidity, 80% of these patients went on to have an emergency cesarean section. For this reason, the high risk of emergency cesarean should be discussed during shared decision-making, the study authors said.

Avoiding unnecessary cesarean deliveries is crucial to limiting the occurrence of low-lying placenta, placenta previa, vasa previa, and placenta accreta spectrum in subsequent pregnancies, Dr. Sentilhes told this news organization. “We hope that our results will help caregivers to objectively advise their patients with low-lying placenta regarding the choice of their mode of delivery.”

“This is further evidence to reassure clinicians that managing such patients with labor is a reasonable approach,” said Aaron B. Caughey, MD, MPH, PhD, professor and chair of the department of obstetrics and gynecology at Oregon Health & Science University, Portland. He was not involved in the study.

Many obstetricians have practiced this for decades, noted Dr. Caughey, associate dean for women’s health research and policy at Oregon Health. “We manage these patients expectantly with a plan for a trial of labor.”

“I am absolutely in agreement,” said Sarah L. Pachtman, MD, an obstetrician-gynecologist at Long Island Jewish Medical Center in New York, who is an independent expert. Dr. Pachtman noted that since she works at a hospital equipped for emergency cesarean deliveries, “I can get a baby out in 5 minutes if necessary.”

Dr. Pachtman’s practice consists of “a very large population of women who strongly desire vaginal delivery.

“It’s a better recovery for them, avoids the risks of abdominal surgery, gives them quicker skin-to-skin contact with their newborn and they can start breastfeeding sooner,” she said in an interview. “And the risk of bleeding is actually lower compared to elective cesarean delivery.”

Deciding on the mode of delivery should be based on patient preference and physician comfort, shared decision-making, and where the patient delivers, Dr. Pachtman said. “If the placental edge is between 1 mm and 10 mm or abutting the internal os, I explain to the patient that there is a risk of bleeding even before labor starts, and they would most likely want to choose an elective cesarean delivery.”

Although low-lying placenta can be associated with significant maternal and neonatal morbidity and mortality, particularly when diagnosed at delivery, universal cervical length screening during routine anatomic ultrasound is identifying the presence of low-lying placenta much earlier in pregnancy.

“We’re identifying it more, following it more, and reporting it more,” Dr. Pachtman said. And in the vast majority of patients, she emphasized, the 28-week follow-up transvaginal ultrasound shows that the low-lying placenta has resolved.

Dr. Sentilhes reported a relationship with Ferring Laboratories. No other study authors disclosed having conflicts of interest. Dr. Caughey and Dr. Pachtman reported having no conflicts of interest.

About half of women with an asymptomatic low-lying placenta in the third trimester and an internal os distance of 11-20 mm can have a vaginal birth after 35 weeks without any higher risk of severe complications than if they had undergone elective cesarean delivery, a new study indicates.

The retrospective analysis of 128,233 births between 2007 and 2012 at six hospitals in France showed that of the 171 women (0.13%) with low-lying placenta, 70 underwent a trial of labor, and 101 had an elective cesarean delivery. The vaginal delivery rate was 50.0% in the group of 38 women with an internal os distance of 11-20 mm, and 18.5% among 27 women with an internal os distance of 1-10 mm.

Similar rates of severe postpartum hemorrhage (PPH) were observed whether the patient opted for a trial of labor or for elective cesarean delivery (22.9% vs. 23.0%), regardless of maternal age, prepregnancy body mass index, nulliparity, and previous cesarean delivery. Rates of severe maternal and neonatal morbidity were 2.9% vs. 2.0%, and 12.9% vs. 9.9%, respectively, both nonsignificantly different, the study showed.

These findings confirm results from an earlier study and could reduce the incidence of unnecessary cesarean deliveries in women with low-lying placenta, said researchers led by Loïc Sentilhes, MD, PhD, of the department of obstetrics and gynecology at Bordeaux (France) University Hospital Center.

“Our results support a policy of offering a trial of labor to women with low-lying placenta at or after 35 weeks of gestation and a distance of 11-20 mm between the placental edge and the internal os on ultrasonography,” they wrote in Obstetrics & Gynecology.

Although an internal os distance of 1-10 mm did not increase the incidence of severe PPH or other severe maternal morbidity, 80% of these patients went on to have an emergency cesarean section. For this reason, the high risk of emergency cesarean should be discussed during shared decision-making, the study authors said.

Avoiding unnecessary cesarean deliveries is crucial to limiting the occurrence of low-lying placenta, placenta previa, vasa previa, and placenta accreta spectrum in subsequent pregnancies, Dr. Sentilhes told this news organization. “We hope that our results will help caregivers to objectively advise their patients with low-lying placenta regarding the choice of their mode of delivery.”

“This is further evidence to reassure clinicians that managing such patients with labor is a reasonable approach,” said Aaron B. Caughey, MD, MPH, PhD, professor and chair of the department of obstetrics and gynecology at Oregon Health & Science University, Portland. He was not involved in the study.

Many obstetricians have practiced this for decades, noted Dr. Caughey, associate dean for women’s health research and policy at Oregon Health. “We manage these patients expectantly with a plan for a trial of labor.”

“I am absolutely in agreement,” said Sarah L. Pachtman, MD, an obstetrician-gynecologist at Long Island Jewish Medical Center in New York, who is an independent expert. Dr. Pachtman noted that since she works at a hospital equipped for emergency cesarean deliveries, “I can get a baby out in 5 minutes if necessary.”

Dr. Pachtman’s practice consists of “a very large population of women who strongly desire vaginal delivery.

“It’s a better recovery for them, avoids the risks of abdominal surgery, gives them quicker skin-to-skin contact with their newborn and they can start breastfeeding sooner,” she said in an interview. “And the risk of bleeding is actually lower compared to elective cesarean delivery.”

Deciding on the mode of delivery should be based on patient preference and physician comfort, shared decision-making, and where the patient delivers, Dr. Pachtman said. “If the placental edge is between 1 mm and 10 mm or abutting the internal os, I explain to the patient that there is a risk of bleeding even before labor starts, and they would most likely want to choose an elective cesarean delivery.”

Although low-lying placenta can be associated with significant maternal and neonatal morbidity and mortality, particularly when diagnosed at delivery, universal cervical length screening during routine anatomic ultrasound is identifying the presence of low-lying placenta much earlier in pregnancy.

“We’re identifying it more, following it more, and reporting it more,” Dr. Pachtman said. And in the vast majority of patients, she emphasized, the 28-week follow-up transvaginal ultrasound shows that the low-lying placenta has resolved.

Dr. Sentilhes reported a relationship with Ferring Laboratories. No other study authors disclosed having conflicts of interest. Dr. Caughey and Dr. Pachtman reported having no conflicts of interest.

About half of women with an asymptomatic low-lying placenta in the third trimester and an internal os distance of 11-20 mm can have a vaginal birth after 35 weeks without any higher risk of severe complications than if they had undergone elective cesarean delivery, a new study indicates.

The retrospective analysis of 128,233 births between 2007 and 2012 at six hospitals in France showed that of the 171 women (0.13%) with low-lying placenta, 70 underwent a trial of labor, and 101 had an elective cesarean delivery. The vaginal delivery rate was 50.0% in the group of 38 women with an internal os distance of 11-20 mm, and 18.5% among 27 women with an internal os distance of 1-10 mm.

Similar rates of severe postpartum hemorrhage (PPH) were observed whether the patient opted for a trial of labor or for elective cesarean delivery (22.9% vs. 23.0%), regardless of maternal age, prepregnancy body mass index, nulliparity, and previous cesarean delivery. Rates of severe maternal and neonatal morbidity were 2.9% vs. 2.0%, and 12.9% vs. 9.9%, respectively, both nonsignificantly different, the study showed.

These findings confirm results from an earlier study and could reduce the incidence of unnecessary cesarean deliveries in women with low-lying placenta, said researchers led by Loïc Sentilhes, MD, PhD, of the department of obstetrics and gynecology at Bordeaux (France) University Hospital Center.

“Our results support a policy of offering a trial of labor to women with low-lying placenta at or after 35 weeks of gestation and a distance of 11-20 mm between the placental edge and the internal os on ultrasonography,” they wrote in Obstetrics & Gynecology.

Although an internal os distance of 1-10 mm did not increase the incidence of severe PPH or other severe maternal morbidity, 80% of these patients went on to have an emergency cesarean section. For this reason, the high risk of emergency cesarean should be discussed during shared decision-making, the study authors said.

Avoiding unnecessary cesarean deliveries is crucial to limiting the occurrence of low-lying placenta, placenta previa, vasa previa, and placenta accreta spectrum in subsequent pregnancies, Dr. Sentilhes told this news organization. “We hope that our results will help caregivers to objectively advise their patients with low-lying placenta regarding the choice of their mode of delivery.”

“This is further evidence to reassure clinicians that managing such patients with labor is a reasonable approach,” said Aaron B. Caughey, MD, MPH, PhD, professor and chair of the department of obstetrics and gynecology at Oregon Health & Science University, Portland. He was not involved in the study.

Many obstetricians have practiced this for decades, noted Dr. Caughey, associate dean for women’s health research and policy at Oregon Health. “We manage these patients expectantly with a plan for a trial of labor.”

“I am absolutely in agreement,” said Sarah L. Pachtman, MD, an obstetrician-gynecologist at Long Island Jewish Medical Center in New York, who is an independent expert. Dr. Pachtman noted that since she works at a hospital equipped for emergency cesarean deliveries, “I can get a baby out in 5 minutes if necessary.”

Dr. Pachtman’s practice consists of “a very large population of women who strongly desire vaginal delivery.

“It’s a better recovery for them, avoids the risks of abdominal surgery, gives them quicker skin-to-skin contact with their newborn and they can start breastfeeding sooner,” she said in an interview. “And the risk of bleeding is actually lower compared to elective cesarean delivery.”

Deciding on the mode of delivery should be based on patient preference and physician comfort, shared decision-making, and where the patient delivers, Dr. Pachtman said. “If the placental edge is between 1 mm and 10 mm or abutting the internal os, I explain to the patient that there is a risk of bleeding even before labor starts, and they would most likely want to choose an elective cesarean delivery.”

Although low-lying placenta can be associated with significant maternal and neonatal morbidity and mortality, particularly when diagnosed at delivery, universal cervical length screening during routine anatomic ultrasound is identifying the presence of low-lying placenta much earlier in pregnancy.

“We’re identifying it more, following it more, and reporting it more,” Dr. Pachtman said. And in the vast majority of patients, she emphasized, the 28-week follow-up transvaginal ultrasound shows that the low-lying placenta has resolved.

Dr. Sentilhes reported a relationship with Ferring Laboratories. No other study authors disclosed having conflicts of interest. Dr. Caughey and Dr. Pachtman reported having no conflicts of interest.